{"id":18185,"date":"2026-05-13T09:48:04","date_gmt":"2026-05-13T08:48:04","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/blog\/non-classifiee\/comprendre-la-reglementation-americaine-sur-les-ecrans-solaires-et-les-exigences-de-la-fda-en-matiere-de-vente-libre\/"},"modified":"2026-05-13T09:48:04","modified_gmt":"2026-05-13T08:48:04","slug":"comprendre-la-reglementation-americaine-sur-les-ecrans-solaires-et-les-exigences-de-la-fda-en-matiere-de-vente-libre","status":"publish","type":"post","link":"https:\/\/www.certifiedcosmetics.com\/fr\/blog\/conformite-reglementaire\/comprendre-la-reglementation-americaine-sur-les-ecrans-solaires-et-les-exigences-de-la-fda-en-matiere-de-vente-libre\/","title":{"rendered":"Comprendre la r\u00e9glementation am\u00e9ricaine sur les \u00e9crans solaires et les exigences de la FDA en mati\u00e8re de vente libre"},"content":{"rendered":"<p data-start=\"0\" data-end=\"459\">Aux \u00c9tats-Unis, les produits de protection solaire sont r\u00e9glement\u00e9s comme des m\u00e9dicaments en vente libre et non comme des cosm\u00e9tiques. La raison en est li\u00e9e \u00e0 l&#8217;usage auquel ils sont destin\u00e9s. Comme ils sont commercialis\u00e9s pour aider \u00e0 pr\u00e9venir les coups de soleil et \u00e0 r\u00e9duire les risques li\u00e9s aux rayons ultraviolets, notamment le vieillissement pr\u00e9matur\u00e9 de la peau et le cancer de la peau, ils rel\u00e8vent de la r\u00e9glementation sur les m\u00e9dicaments de la FDA. Cela change presque tout pour les entreprises qui entrent sur le march\u00e9 am\u00e9ricain, de la formulation et des tests \u00e0 la fabrication et \u00e0 l&#8217;\u00e9tiquetage.   <\/p>\n<h2 data-section-id=\"11sv9xr\" data-start=\"461\" data-end=\"496\">Le cadre de la FDA pour les \u00e9crans solaires<\/h2>\n<p data-start=\"498\" data-end=\"706\"><img decoding=\"async\" class=\"wp-image-17719 alignright\" src=\"https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-640x640.jpg\" alt=\"\" width=\"324\" height=\"324\" srcset=\"https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-640x640.jpg 640w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-160x160.jpg 160w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-768x768.jpg 768w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-320x320.jpg 320w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-400x400.jpg 400w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-300x300.jpg 300w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-600x600.jpg 600w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-100x100.jpg 100w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-60x60.jpg 60w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc-110x110.jpg 110w, https:\/\/www.certifiedcosmetics.com\/wp-content\/uploads\/2026\/05\/sunscreen_us_otc.jpg 800w\" sizes=\"(max-width: 324px) 100vw, 324px\" \/>Les cr\u00e8mes solaires vendues aux \u00c9tats-Unis suivent g\u00e9n\u00e9ralement le syst\u00e8me de monographie OTC de la FDA. Ce cadre permet aux produits d&#8217;entrer sur le march\u00e9 sans approbation individuelle de la FDA, \u00e0 condition qu&#8217;ils remplissent des conditions sp\u00e9cifiques de monographie. <\/p>\n<p data-start=\"708\" data-end=\"737\">La monographie fixe des r\u00e8gles pour :<\/p>\n<ul data-start=\"739\" data-end=\"914\">\n<li data-section-id=\"1h85omx\" data-start=\"739\" data-end=\"770\">Ingr\u00e9dients actifs approuv\u00e9s<\/li>\n<li data-section-id=\"wpg8sf\" data-start=\"771\" data-end=\"795\">Limites de concentration<\/li>\n<li data-section-id=\"1wgxweu\" data-start=\"796\" data-end=\"812\">Formes de dosage<\/li>\n<li data-section-id=\"x2773y\" data-start=\"813\" data-end=\"846\">Revendications SPF et large spectre<\/li>\n<li data-section-id=\"bvvrbg\" data-start=\"847\" data-end=\"874\">Avertissements et instructions<\/li>\n<li data-section-id=\"11ycws2\" data-start=\"875\" data-end=\"894\">M\u00e9thodes de test<\/li>\n<li data-section-id=\"gb2ysb\" data-start=\"895\" data-end=\"914\">Structure de l&#8217;\u00e9tiquette<\/li>\n<\/ul>\n<p data-start=\"916\" data-end=\"1029\">Les produits qui r\u00e9pondent \u00e0 ces exigences sont consid\u00e9r\u00e9s comme <strong>g\u00e9n\u00e9ralement reconnus comme s\u00fbrs et efficaces<\/strong>, ou <strong>GRASE<\/strong>.<\/p>\n<h2 data-section-id=\"1oa1cak\" data-start=\"1031\" data-end=\"1059\">Le statut de l&#8217;ingr\u00e9dient est important<\/h2>\n<p data-start=\"1061\" data-end=\"1194\">Le statut r\u00e9glementaire des actifs de la cr\u00e8me solaire joue un r\u00f4le majeur dans la strat\u00e9gie du produit. La FDA s\u00e9pare les ingr\u00e9dients en cat\u00e9gories telles que : <\/p>\n<ul data-start=\"1196\" data-end=\"1308\">\n<li data-section-id=\"mk60fq\" data-start=\"1196\" data-end=\"1228\">Ingr\u00e9dients consid\u00e9r\u00e9s comme GRASE<\/li>\n<li data-section-id=\"enpttb\" data-start=\"1229\" data-end=\"1271\">Ingr\u00e9dients n\u00e9cessitant plus de donn\u00e9es de s\u00e9curit\u00e9<\/li>\n<li data-section-id=\"ty7hsz\" data-start=\"1272\" data-end=\"1308\">Ingr\u00e9dients non consid\u00e9r\u00e9s comme GRASE<\/li>\n<\/ul>\n<p data-start=\"1310\" data-end=\"1501\">Les filtres UV min\u00e9raux comme l&#8217;oxyde de zinc et le dioxyde de titane sont largement accept\u00e9s dans les conditions actuelles. Certains filtres UV organiques n\u00e9cessitent encore une \u00e9valuation suppl\u00e9mentaire avant une classification d\u00e9finitive. <\/p>\n<h2 data-section-id=\"o66yy1\" data-start=\"1503\" data-end=\"1544\">Attentes en mati\u00e8re de tests et de fabrication<\/h2>\n<p data-start=\"1546\" data-end=\"1849\">R\u00e9pondre aux exigences de la monographie ne se limite pas \u00e0 la s\u00e9lection d&#8217;ingr\u00e9dients approuv\u00e9s. Les entreprises doivent \u00e9tayer leurs all\u00e9gations par des m\u00e9thodes de test reconnues, qui peuvent inclure des tests de FPS, une \u00e9valuation du large spectre, des \u00e9tudes de r\u00e9sistance \u00e0 l&#8217;eau, des donn\u00e9es de stabilit\u00e9, des contr\u00f4les de qualit\u00e9 microbiologique et des \u00e9valuations de la s\u00e9curit\u00e9. <\/p>\n<p data-start=\"1851\" data-end=\"2157\">Les normes de fabrication sont plus strictes que les exigences des BPF pour les cosm\u00e9tiques. La conformit\u00e9 aux BPF des m\u00e9dicaments comprend souvent des processus valid\u00e9s, des syst\u00e8mes de qualit\u00e9, des contr\u00f4les en laboratoire, la tra\u00e7abilit\u00e9 des lots, des proc\u00e9dures de contr\u00f4le des modifications et des syst\u00e8mes de rappel. Les sites de fabrication \u00e9trangers peuvent \u00e9galement \u00eatre soumis \u00e0 l&#8217;autorit\u00e9 d&#8217;inspection de la FDA.  <\/p>\n<h2 data-section-id=\"lm8ejp\" data-start=\"2159\" data-end=\"2195\">Enregistrement, frais et surveillance<\/h2>\n<p data-start=\"2197\" data-end=\"2477\">Avant la commercialisation, les entreprises ont g\u00e9n\u00e9ralement besoin de l&#8217;enregistrement de l&#8217;\u00e9tablissement aupr\u00e8s de la FDA, de l&#8217;inscription du produit, de l&#8217;attribution du num\u00e9ro NDC et de la v\u00e9rification de la conformit\u00e9 de l&#8217;\u00e9tiquette. Les \u00e9tablissements qui fabriquent des produits solaires en vente libre sont soumis aux frais de l&#8217;OMUFA, qui s&#8217;appliquent aussi bien aux sites nationaux qu&#8217;aux sites \u00e9trangers. <\/p>\n<p data-start=\"2479\" data-end=\"2694\">Les entreprises \u00e9trang\u00e8res doivent nommer un agent am\u00e9ricain lors de l&#8217;enregistrement aupr\u00e8s de la FDA. L&#8217;agent sert de point de contact avec la FDA pour l&#8217;\u00e9tablissement \u00e9tranger, bien que la responsabilit\u00e9 r\u00e9glementaire ne soit transf\u00e9r\u00e9e que si elle est d\u00e9finie par contrat. <\/p>\n<h2 data-section-id=\"jdlchs\" data-start=\"2696\" data-end=\"2727\">Probl\u00e8mes d&#8217;entr\u00e9e dans le march\u00e9 commun<\/h2>\n<p data-start=\"2729\" data-end=\"3031\">Quelques probl\u00e8mes reviennent r\u00e9guli\u00e8rement lors des lancements de cr\u00e8mes solaires aux \u00c9tats-Unis. Certaines entreprises supposent que les \u00e9crans solaires sont r\u00e9glement\u00e9s comme les cosm\u00e9tiques. D&#8217;autres utilisent des ingr\u00e9dients actifs non autoris\u00e9s, font des all\u00e9gations qui ne sont pas autoris\u00e9es par la FDA, sous-estiment la complexit\u00e9 des tests ou op\u00e8rent dans des installations qui ne r\u00e9pondent pas aux <strong>normes de bonnes pratiques de fabrication des m\u00e9dicaments<\/strong>.  <\/p>\n<p data-start=\"3033\" data-end=\"3307\" data-is-last-node=\"\" data-is-only-node=\"\">Une entr\u00e9e r\u00e9ussie sur le march\u00e9 d\u00e9pend g\u00e9n\u00e9ralement d&#8217;une planification r\u00e9glementaire pr\u00e9coce portant sur la formulation, l&#8217;\u00e9tiquetage, les tests, la fabrication et les obligations post-commercialisation. M\u00eame sans l&#8217;approbation d&#8217;un produit individuel, la conformit\u00e9 des \u00e9crans solaires aux \u00c9tats-Unis reste <strong>tr\u00e8s technique et \u00e9troitement r\u00e9glement\u00e9e<\/strong>. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Aux \u00c9tats-Unis, les produits de protection solaire sont r\u00e9glement\u00e9s comme des m\u00e9dicaments en vente libre et non comme des cosm\u00e9tiques. La raison en est li\u00e9e \u00e0 l&#8217;usage auquel ils sont destin\u00e9s. Comme ils sont commercialis\u00e9s pour aider \u00e0 pr\u00e9venir les coups de soleil et \u00e0 r\u00e9duire les risques li\u00e9s aux rayons ultraviolets, notamment le vieillissement&#8230;<\/p>\n","protected":false},"author":294,"featured_media":17722,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[328],"tags":[],"class_list":["post-18185","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-conformite-reglementaire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.4 (Yoast SEO v25.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Comprendre la r\u00e9glementation am\u00e9ricaine sur les \u00e9crans solaires et les exigences de la FDA en mati\u00e8re de vente libre - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"Aux \u00c9tats-Unis, les \u00e9crans solaires sont r\u00e9glement\u00e9s en tant que m\u00e9dicaments en vente libre. 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